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Active Not Recruiting NCT05520099

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)

Conditions: Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder, Kidney Cancer, Clear Cell Renal Cell Cancer (ccRCC), Colorectal Cancer, MSI-H Colorectal Cancer, DMMR Colorectal Cancer, Head and Neck Cancer (H&N), Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Liver Cancer, Hepatocellular Carcinoma (HCC), Lung Cancer (NSCLC), NSCLC (Non-small Cell Lung Cancer), Skin Cancer, Cutaneous Melanoma, Endometrial Cancer, Solid Tumor Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 416
Sponsor: Elephas

Location: CARTI Cancer Center Little Rock Arkansas

Summary

The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method

Eligibility Criteria

Inclusion Criteria -- 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. Subjects must meet one of the following criteria: * Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer: * Bladder: Urothelial Carcinoma (UC) * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC) * Subjects suspected or diagnosed with recurrent or metastatic cancer: * Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC) * Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers * Liver: Hepatocellular Carcinoma * Lung: Non-small cell lung cancer (NSCLC) * Skin: Cutaneous Melanoma, excluding Uveal Melanoma * Uterus: endometrial cancer * Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy: o Skin: Cutaneous Melanoma, Stage III * Subjects suspected or diagnosed with: * Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting * Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy. * Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy. 4. Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure 5. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment. Exclusion Criteria -- 1. Subjects who are pregnant 2. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment 3. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy 4. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05520099). StuddyBuddy aggregates publicly available trial information.